Low FODMAP Diet in Patients With IBS
Primary Purpose
Irritable Bowel Syndrome
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
variations of the low FODMAP diet
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Carbohydrates, low FODMAP diet, components in the low FODMAP diet
Eligibility Criteria
Inclusion Criteria: IBS diagnosed by the Rome III criteria and referred to treatment by diet - Exclusion Criteria: Dementia, and lack of ability to speak Danish or other conditions prevailing participation -
Sites / Locations
- University of Copenhagen
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
low FODMAP diet
Arm Description
Cross-over design with 3 variations
Outcomes
Primary Outcome Measures
Birmingham IBS questionnaire and adequate relief (IBS-AR).
Score in points
Secondary Outcome Measures
IBS Quality of Life Scale questionnaire (IBS-QOL)
Score in points
Full Information
NCT ID
NCT05618106
First Posted
November 8, 2022
Last Updated
November 8, 2022
Sponsor
Jens Rikardt Andersen
1. Study Identification
Unique Protocol Identification Number
NCT05618106
Brief Title
Low FODMAP Diet in Patients With IBS
Official Title
Modification of the Low FODMAP Diet in Treatment of Irritable Bowel Syndrome: A Randomised Cross-over Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
February 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jens Rikardt Andersen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
We aimed to investigate if all carbohydrate groups eliminated in the Low FODMAP diet are equally important in relieving gastrointestinal symptoms in IBS.
in a randomised cross-over design to three different carbohydrate-modified diets: A) Low Polyol diet, B) Low FOS+GOS diet, and C) Low FODMAP diet for three months without wash-out-periods. Gastrointestinal symptoms, Quality of life was measured at baseline and after each intervention diet.
Detailed Description
Low FODMAP diets contain 3 major types of carbohydrates to be avoided. The clasical diet is very difficult to maintain over longer periods of time. Therefore, we aimed to investigate if all carbohydrate groups in the Low FODMAP diet are equally important in relieving gastrointestinal symptoms in IBS.
Patients diagnosed with IBS according to the Rome III criteria were randomised in a cross-over design to three different carbohydrate-modified diets: A) Low Polyol diet, B) Low FOS+GOS diet, and C) Low FODMAP diet for a total of three months without wash-out-periods. Gastrointestinal symptoms were assessed by the Birmingham IBS questionnaire and adequate relief (IBS-AR). Quality of life was measured by the IBS Quality of Life Scale questionnaire (IBS-QOL). All registrations were performed at baseline and after each intervention diet.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Carbohydrates, low FODMAP diet, components in the low FODMAP diet
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Cross-over of 3 variations of the low FODMAP diet excluding 1 of the 3 components in every period
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
low FODMAP diet
Arm Type
Experimental
Arm Description
Cross-over design with 3 variations
Intervention Type
Other
Intervention Name(s)
variations of the low FODMAP diet
Intervention Description
Cross-over of 3 interventions in IBS patients:
Low Polyol diet
Low FOS+GOS diet
Low FODMAP diet
Primary Outcome Measure Information:
Title
Birmingham IBS questionnaire and adequate relief (IBS-AR).
Description
Score in points
Time Frame
3 months
Secondary Outcome Measure Information:
Title
IBS Quality of Life Scale questionnaire (IBS-QOL)
Description
Score in points
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: IBS diagnosed by the Rome III criteria and referred to treatment by diet -
Exclusion Criteria: Dementia, and lack of ability to speak Danish or other conditions prevailing participation
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens R Andersen, MD, MPA
Organizational Affiliation
University of Copenhagen
Official's Role
Study Chair
Facility Information:
Facility Name
University of Copenhagen
City
Copenhagen
State/Province
Frederiksberg
ZIP/Postal Code
1958
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
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Low FODMAP Diet in Patients With IBS
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